NCT00015288

Brief Summary

The purpose of this study is to examine pharmacokinetics and dose proportionality of sublingual tablets containing varying doses of buprenorphine and naloxone.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1996

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 18, 2001

Completed
Last Updated

January 12, 2017

Status Verified

August 1, 1998

First QC Date

April 18, 2001

Last Update Submit

January 11, 2017

Conditions

Heroin DependenceOpioid-Related Disorders

Outcome Measures

Primary Outcomes (3)

  • Physiological measures

  • Measurements of buprenorphine and naloxone in plasma

  • Subjective symptoms measures

Interventions

Buprenorphine/naloxoneDRUG

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male/Female between the ages of 21 and 45. Within 15% of ideal body weight. No oral pathology that would interfere with the sublingual absorption of the medication. Experienced in the use of opiates but not dependent.

You may not qualify if:

  • LFT's exceeding than 3x's normal. History of seizure. Opiate dependent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York MDRU

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Heroin DependenceOpioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BuprenorphineMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsNaloxoneHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • John Rotrosen, M.D.

    New York MDRU

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

April 18, 2001

First Posted

April 18, 2001

Study Start

November 1, 1996

Last Updated

January 12, 2017

Record last verified: 1998-08

Locations

US(1)